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Vaccination, an Overview, Part 3 The New Epidemic

In America today, what infectious diseases remain, such as the flu, are not as life-threatening, and infant mortality has drastically decreased from just a century ago. Children of today are highly likely to make it to adulthood. Coinciding with the reduction of infectious disease, however, has been a corresponding emergence of an entirely new kind of health problem in children: chronic disease. Children in ever greater numbers are suffering from immune system disorders and developmental delays which have no known cause or cure. Eczema, hives, hay fever and food sensitivities have been increasing since the 1920s, with rapid surges occurring in the 1960s and the 1980s, and these allergies now occur in the tens of millions. Asthma has been increasing since the 1960s, particularly in developed countries, and it now affects 6 million children in the U.S. Attention-Deficit Hyperactivity Disorder has tripled in incidence since the 1970s. Autism spectrum disorders have grown from 1 in 2,000 in the 1960s and 1970s to 1 in 150 today, with the greatest spike occurring from 1996 to 2007. All of these increases in incidence are too great to be explained solely by genetic mutations (although genetic susceptibility does seem to be a factor) or by evolving diagnostic methods and definitions. Consequently, an external, environmental agent (or agents) must be triggering them. Since these diseases are chronic but seem to be unassociated with any pathogen and not infectious, they cannot be explained by the germ theory of disease, and scientists possess no alternative theory that would explain what in our environment could be triggering these types of health problems.

It is worth noting that our environment has changed drastically over the last half-century. Our food, water and air are less likely to be contaminated by bacteria like tuberculosis or cholera but are more likely to contain pesticides and other potentially toxic chemicals. Children who used to run and play outdoors, using up their excess energy and exposing their immune systems to many different natural substances, from pollen to poison ivy, now spend most of their time indoors in school or sitting still in front of a screen at home. At the same time they have adopted diets high in excess calories and low in nutrients. Antibiotics and pasteurization have reduced the presence of both bad and good bacteria in their lives. This new lifestyle could be the culprit for children’s hypersensitive immune systems and hyperactive behavior, or it could at least be a contributor. When it comes to autism spectrum disorders, however, many parents believe that vaccines play a major role.

Vaccines have never been completely without side effects, and even the safest vaccines will cause temporary side effects (such as pain and swelling, fever, vomiting, diarrhea, rashes, headaches and crying) between 5% and 40% of the time. Serious side effects are usually some form of inflammation: Guillain-Barre syndrome (an autoimmune disorder causing paralysis) and encephalitis (inflammation of the brain). However, these are said to be extremely rare. A vaccine for which the serious side effects were found to be relatively more common was the first combination vaccine, DTP (diphtheria, tetanus and pertussis), which was released on the market in 1946. In the 1970s and 1980s there was a growing awareness that the pertussis portion of the vaccine, which used a whole-cell B. pertussis bacteria, was responsible for a higher-than-expected rate of reactions such as convulsions, shock, cardiac distress and brain damage. In 1981 Japanese scientists developed a new vaccine that used a safer acellular pertussis component, and caused far fewer reactions, but this form of the vaccine was only adopted in the United States in 1996, after many years of lobbying by parents who had observed their children react adversely to the DTP vaccine.

As was the case with the DTP vaccine, suspicions of a link between autism and vaccines have their initial basis in the case reports of parents who see their children lose previously acquired mental and social skills following doses of vaccines, the majority of which are administered in the first two years of life, the same timespan in which autism usually appears. This correlation could be explained as a coincidence, but the issue is complicated by the fact the rates of autism have increased in conjunction with rising number of shots given to children. In 1983, for example, children received vaccines for diphtheria, tetanus, pertussis (given together as DTP), polio, and mumps, measles and rubella (given together as MMR). This schedule represented vaccines for 7 diseases in the first 4 years. There were 6 shots containing 18 doses of vaccines plus an additional 4 doses of the oral polio vaccine, totaling 22 doses of vaccines. In the year 1995 the schedule was largely the same, except for the addition of the vaccine against Haemophilus Influenzae Type B (HIB) a bacteria that causes meningitis. After that, however, the number of vaccines began to increase. By 2007, children following the standard schedule were receiving 40 total doses of vaccines against 14 diseases, double what had been given a decade previously. At the same time the number of shots did not greatly increase, because new combination vaccines became available that combine four or five vaccines into one shot. The result has been a significant increase in the amount of foreign material injected into a child’s body at one time.

As discussed in last week’s newsletter, the ingredients of a vaccine must be carefully balanced and formulated in order for the vaccine to be both safe and effective. The typical vaccine components mentioned in the first section – the pathogen, the tissues in which it is cultured, an adjuvant to help stimulate immunity, and a preservative to protect the vaccine from additional pathogens – are each capable of causing unwanted side effects.Live viruses and bacteria, found in the DPT and MMR vaccines among others, are better able to stimulate immunity, but are more likely than weak or killed pathogens to cause a persistent infection and excessive inflammation, including inflammation of the brain (encephalitis) and subsequent brain damage. Animal or human tissues in which pathogens are cultured contain proteins similar to those contained in our own tissues. In reacting to the pathogen in a vaccine, some immune systems may see these proteins as part of the threat, and produce autoantibodies against them. These autoantibodies can’t tell the difference between the injected proteins and body’s proteins, resulting in chronic inflammatory autoimmune disease such as Guillain-Barre syndrome, arthritis or multiple sclerosis. The most typical adjuvant in vaccines, aluminum, is a metal that has been linked to Alzheimer’s disease, dementia and brain damage, and it may be difficult for some children to detoxify. As for preservatives, some vaccines contain formaldehyde, a carcinogen, and most vaccines previously contained thiomersal, a form of mercury, before vaccine manufacturers agreed to provide mercury-free vaccines upon request several years ago. Could these ingredients, as they are injected into children with greater frequency and in greater quantities, be responsible for the increasing incidence of chronic immune hypersensivity and developmental disorders in children? Clearly, not all children have negative long-term reactions to vaccines; in fact, it seems that most of them don’t. But might some children have a genetic susceptibility to having adverse reactions to vaccines, particularly when administered according to the current schedule?

What are the facts of the situation? First, vaccines carry the potential for adverse effects, including brain damage. Second, there is a parallel between increasing autism rates and the increased number of vaccines given. Last, autism typically emerges in children during the period of time when vaccines are administered. What have we proved? Nothing. These facts are not proof of a causal relationship between vaccines and autism–they only show a correlation. However, this correlation makes a causal relationship a possibility worth investigating, especially since no other cause of autism has been identified. Accordingly, many scientific studies have been done on whether a link between vaccines and autism exists. The initial safety studies done on each new vaccine by Merck, Sanofi Pasteur, Wyeth, and GlaxoSmithKline (the four large pharmaceutical companies that manufacture almost all vaccines), the results of which are reviewed by the FDA and the CDC’s Vaccine Adverse Events Reporting System (VAERS), have not found a link for any individual vaccine. Doctors and research scientists, most notably the independent, non-profit Institute of Medicine, have conducted many additional studies over the past two decades, as well as comprehensive reviews of earlier research, and the vast majority of them have also concluded that no link can be proven, thus confirming the scientific consensus that the serious side effects of vaccines are extremely rare and do not include autism.

The most famous study that did hint at a possible connection between vaccines and autism was published in 1998 in The Lancet, a British medical journal that is perhaps the most respected in the world. The lead author, Dr. Andrew Wakefield, and twelve of his colleagues, argued, based on observations of twelve children with both inflammatory bowel disease and autism, that the children might have a new syndrome caused by the vaccine-strain measles virus, which was found in their intestines. Because the children were previously normal, Dr. Wakefield suggested an environmental trigger might be the cause of the syndrome, and called for the MMR vaccine (measles-mumps-rubella combination) to be discontinued in favor of separate vaccines administered at separate times, until more research could be done. However, the British government felt that to do so would increase the exposure of children to the three diseases. The results of the study were widely reported in the news media, and with MMR remaining the only vaccine available, many parents did not vaccinate their children against the diseases at all.

In the years that followed, both Wakefield and the study received increasing criticism. Other scientists did similar studies and reported that they had failed to duplicate the results. A journalist investigating Wakefield found that he had ties to a lawyer preparing a lawsuit against the MMR manufacturers, and that he had a patent on a new measles vaccine, both indicative of serious conflicts of interest. Ten of the twelve co-authors eventually disowned the paper. Earlier this year, The Lancet itself finally retracted the paper, and Dr. Wakefield lost his license to practice medicine in the UK.

In light of this evidence, it would seem that the possibility of any link between vaccines and autism has been thoroughly eliminated. But for a variety of reasons, we must question the credibility of those who signed off on vaccine safety, who authored and reviewed pro-vaccine studies, and who have promoted vaccines in the media. To begin with, the general public has long had good reason to distrust the ethics and integrity of the pharmaceutical industry, which has been known to disguise or minimize knowledge of adverse reactions to its products (such as Avandia, Vioxx and Fen-Phen). It has also been known to aggressively market its products to as wide a customer base as possible — even urging in recent months, with governmental approval, cholesterol-lowering drugs on people who do not even have high cholesterol. Vaccines are a guaranteed lucrative investment, given that they are prescribed equally to almost every individual in the country.

An additional strike against the pharmaceutical companies’ assurances of safety is that they are not responsible for adverse side effects of the vaccines they manufacture. In the 1980s, as more parents whose children had been injured by the DPT vaccine began to bring lawsuits against vaccine manufacturers, those manufacturers threatened to stop making vaccines entirely, reasoning that it would be unprofitable to continue if they had to pay expensive personal injury claims. In order to ensure that vaccines remained available to the public, the U.S. government stepped in and passed the National Childhood Vaccine Injury Act, which set up a special government court for hearing vaccine injury claims, and awarding damages up to $250,000. The damages are funded by proceeds from a tax on vaccines, thus shielding vaccine manufacturers from any financial liability. Claims are argued before a government-appointed judge rather than a jury, and while most claims are rejected, the court has had to award almost $2 billion in damages since its inception.

Clearly, pharmaceutical companies manufacture vaccines for profit, not out of an overriding concern for the safety of children. It is not likely that they would abandon profitable products such as vaccines even if they knew that such products caused relatively frequent and severe side effects–just as they knew, but kept secret, the fact that Avandia increased the risk of heart attacks, for example. It is therefore prudent not to accept at face value claims (and by claims, I mean advertising) by the vaccine manufacturers, and by the scientists whom they employ, that vaccines are extremely safe.

What about the government’s independent oversight and regulatory authority? Unfortunately, as in so many industries (including banking, energy, and health care) a revolving door of employment exists between the pharmaceutical companies and the federal authorities that regulate them. An example is Dr. Julie Gerberding, who directed the CDC from 1998 to 2009. This was the period during which the number of vaccines administered and the number of autism cases greatly increased. Dr. Gerberding waited exactly one year and one day after leaving the CDC – the legal minimum – before taking on the job of President of the Vaccine Division of Merck Pharmaceuticals. Gerberding, during her CDC tenure, heavily promoted Merck’s new-to-the-market HPV vaccine, Gardasil, as well as the safety and effectiveness of vaccines in general.

As for scientists and medical doctors who conduct research on the safety of vaccines, many rely on the financial support of the pharmaceutical companies to carry out their research. Without that support, they would be unable to carry out wide-ranging, long-lasting epidemiological studies of vaccine reactions. The most vocal and media-friendly proponent of vaccine safety, Dr. Paul Offit of the Children’s Hospital in Philadelphia, happens to be the co-inventor of the Rotavirus vaccine RotaTeq (also manufactured by Merck). Offit has received royalties totaling $182 million from RotaTeq alone.

The conflicts of interest described so far have their origin in greed, but some conflicts can arise from humanitarian motivations. Most public health officials have concerns that if doubts about vaccine safety are given a more thorough hearing, a majority of parents might choose to vaccinate their children less, or not at all (as we saw happen in the aftermath of the Wakefield study publication) and consequently return us to an era of epidemic disease rivaling that of the 19th and early 20th centuries. The authorities may be unwilling to give a fair hearing to the possibility of a vaccine-autism link to serve the greater good. It’s possible that, even if Dr. Wakefield was partly right in his conclusions, the government and scientific community may have been driven by these types of fears to dissect his work for errors and conflicts and to magnify those flaws.

With so many powerful institutions – pharmaceutical companies, government, and scientific bodies – motivated for a variety of reasons to disprove a link between vaccines and autism, it is unlikely that any individual scientist or pediatrician is willing to stake their reputation, potentially even their license to practice medicine, by publishing (or even conducting) a study indicating greater-than-reported side effects of vaccines. Not only would funding for such a study be difficult to obtain, any flaws in its methodology will be far more heavily scrutinized than if it were to confirm what has already been promoted as scientific truth.

If so many conflicts of interest are at work, shouldn’t we expect to see weaknesses in the pro-vaccine studies? In fact, on closer examination, many of the studies showing that vaccines are unrelated to autism have significant methodological flaws or are reported to have broader conclusions than they really do. To take a recent example, an epidemiological study by researchers from the University of Louisville School of Medicine was published in Pediatrics magazine on May 24th of this year, stating that giving children vaccines on schedule had no negative effect on long-term neurodevelopment. Most news outlets reported that the study had shattered the “myth” that a delayed or alternative vaccine schedule was safer than the standard, CDC-recommended schedule. However, the study was based on data from a 2007 study published in the New England Journal of Medicine intended to determine whether increased amounts of thiomersal in vaccines caused greater numbers of neuropsychological disorders. That study contained a disclaimer noting that children with autism spectrum disorders were specifically excluded from the data set. Consequently, such children were not examined in the recent study either, and the authors acknowledged that they were restricted in their ability to assess outcomes such as neuro-developmental delay, autism, and autoimmune disorders. The differences between the two groups that were compared were also not significant. Those who were placed in the “timely” group received the recommended 10 vaccines in their first seven months while the “untimely” group received an average of 8. The untimely group, though their shots were delayed, did not actually receive fewer vaccines at each doctor visit, and the study indicates that they may have missed vaccines for socioeconomic reasons rather than intentionally abiding by a different schedule. Finally, the study was only of children receiving shots from 1993 to 1997, the period just prior to that in which the number of vaccine shots increased dramatically.

While, as stated above, these types of omissions and flaws are characteristic of most of the pro-vaccine studies, the fact that Dr. Wakefield’s study has been discredited as well is not necessarily comforting for those wanting to be reassured about the safety of vaccines, as it indicates that his conflicts of interest, as well as an error-filled study, somehow escaped the notice both of the editors of the Lancet and of the dozen co-authors who participated in the research. It must be concluded that we cannot simply take for granted the results of scientific studies from even the best medical journals, having seen what happens when they are subjected to intense scrutiny. And, above all, we must keep in mind that such scrutiny is not likely to be applied to studies that confirm the scientific consensus on vaccines.

To better determine whether a connection might exist between vaccines and autism, we would need a long-term study comparing the health problems of a control group of completely unvaccinated infants against another group that has the standard vaccine schedule, and possibly additional groups that follow selective or alternative vaccine schedules. No study of this type has yet been done. Pro-vaccine groups argue that such a study would be unethical, assuming ahead of time that vaccines are safer than the alternative, though this is what the study would be meant to determine. Though such a study would be expensive, anti-vaccine groups might be able to fund it, were it not for the fact that, having staked their reputations on a link between vaccines and autism, they could not be considered an objective sponsor. Perhaps the main obstacle, however, is that a study of this type would require a large number of children to go unvaccinated and potentially susceptible to disease, and no public or private institution would want to take responsibility and liability for these potential adverse effects. Of course, autism is itself an epidemic that must be addressed, but as long as its cause remains unknown, no institution is officially liable for it. Only the families of autistic children bear the burden for it.

As the controversy rages on, fewer parents are taking the medical establishment (including the CDC) at its word. On May 5th, 2010, the CDC announced the results of a study they had conducted on parental compliance with the current recommended vaccine schedule. The percentage of parents who refused or delayed at least one vaccine for their children had increased from 22% in 2003 to 39% in 2008. Why? The parents cited concerns about the safety of vaccines, particularly the risk of autism. If the risks of vaccines are in fact much greater than reported, these parents seem to be making the right choice. However, one must not forget the reason why we vaccinate in the first place: to protect our children from infectious diseases. Eliminating one of the possible causes of autism from your child’s life won’t do them any good if they suffer permanent damage or death from polio, measles, diphtheria, tetanus or meningitis. Therefore, suspecting that the side effects of vaccines may be greater than reported leaves us with no easy decision to make. The overarching question that remains is the same that has pursued us throughout human history: how do we safely protect our children from disease?

We’ll take a stab at answering that question in next week’s newsletter, “Building Immunity.”